


<p class="MsoNoSpacing"><u><span style="font-family:&quot;Times New Roman&quot;,serif">INSTRUCTIONS
FOR RESPONSE </span></u><b style="mso-bidi-font-weight:normal"><span style="font-family:&quot;Times New Roman&quot;,serif"><o:p></o:p></span></b></p>

<p class="MsoNoSpacing"><span style="font-family:&quot;Times New Roman&quot;,serif">Please
respond to this letter by doing the following:<o:p></o:p></span></p>

<p class="MsoNoSpacing" style="margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo1"><!--[if !supportLists]--><span style="font-family:&quot;Times New Roman&quot;,serif;mso-fareast-font-family:&quot;Times New Roman&quot;"><span style="mso-list:Ignore">1.<span style="font:7.0pt &quot;Times New Roman&quot;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span></span><!--[endif]--><span style="font-family:&quot;Times New Roman&quot;,serif">The
Response to Review document is located on the forms tab.<span style="mso-spacerun:yes">&nbsp; </span><b style="mso-bidi-font-weight:normal">Please
provide your COMPLETE answer to the question in this form in a different font. </b>Please
also state the page number and document<st1:citation w:st="on">(s)</st1:citation>
which were changed in response to the question. The purpose of this "self
contained response document" is to make it easy for the reviewers to fully
understand your responses.<span style="mso-spacerun:yes">&nbsp; </span>Failing to
follow these directions is likely to slow down review of your project. This
format is <u>not</u> required for consent form changes, where it is fine to
make the changes and submit the revised consent form with deletions in red
strike-through, and additions in yellow highlighting. <o:p></o:p></span></p>

<p class="MsoNoSpacing" style="margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo1"><!--[if !supportLists]--><span style="font-family:&quot;Times New Roman&quot;,serif;mso-fareast-font-family:&quot;Times New Roman&quot;"><span style="mso-list:Ignore">2.<span style="font:7.0pt &quot;Times New Roman&quot;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span></span><!--[endif]--><span style="font-family:&quot;Times New Roman&quot;,serif">Incorporate
into the Protocol Summary and any other relevant study documents the changes
outlined in this memo as well as any other changes made to address the
Committee's questions and concerns about the study. Please submit clean and
marked up copies of the revised document<st1:citation w:st="on">(s)</st1:citation>.
<span style="mso-spacerun:yes">&nbsp;</span>This will facilitate the review of your
response.<span style="mso-spacerun:yes">&nbsp; </span>Revising documents ensures
that the study is conducted according to the updated Protocol and will
facilitate continuing review.<o:p></o:p></span></p>

<p class="MsoNormal"><o:p>&nbsp;</o:p></p>


